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TRANSFORMING HEART FAILURE CARE THROUGH CONTINUOUS INNOVATION

The HEART Platform is a multicenter, randomized clinical trial infrastructure designed to improve outcomes for adults with heart failure through the efficient and continuous evaluation of multiple therapeutic interventions.

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OVERVIEW

HEART operates under a shared master protocol framework that allows therapeutic domains to be added, modified, or closed over time as evidence accumulates and new research questions emerge.

Each domain functions as an independent randomized clinical trial (RCT), running everything from pilot and feasibility studies to full trial evaluations. A dedicated Project Lead, Data Management Coordinator, Biostatistician and others form the core team to enable seamless and timely operational delivery of a trial.

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TRIAL DESIGN

  • Interventional platform trial with sequential assignment model

  • Participants randomized within eligible therapeutic domains

  • Concurrent control groups (placebo and/or standard of care, domain-specific)

  • Estimated enrollment: 1,000 participants

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PATIENT POPULATION

  • Worsening Heart Failure (WHF): hospitalized or emergency department patients requiring active management, or those with WHF such as increased diuretics or volume overload as an outpatient.

  • Ambulatory Heart Failure: clinically stable outpatients without recent hospitalization.

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PLATFORM-LEVEL OUTCOMES

  • Default primary endpoint: Time to first occurrence of all-cause death or cardiovascular hospitalization (up to 180 days or as defined in domain protocol).

  • Secondary outcomes include cardiovascular hospitalization, all-cause mortality, heart failure hospitalization, days alive and out of hospital, KCCQ-TSS change, and safety events.

  • Domain-specific endpoints may vary based on intervention and development phase, and add on specific endpoints.

  • All patients are consented to be followed out through 1 year for all clinical event-based outcomes, and where allowed, for health-related data linkages.

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GOVERNANCE & ADMINISTRATION

The HEART Platform includes a Platform Steering Committee and an independent Data Monitoring Committee (DMC). The study is conducted in accordance with Good Clinical Practice, the Declaration of Helsinki, and applicable ethical and regulatory requirements. Ethics approval for the Master protocol is via the Research Ethics Board of the University of Alberta.

Principal Investigator: Justin Ezekowitz, MBBCh, MSc

Sponsor & Responsible Party: University of Alberta

Core Collaborator: Canadian VIGOUR Centre

Funding Partner: University Hospital Foundation & University of Alberta

ClinicalTrials.gov Identifier: NCT07428135